RecruitingNot ApplicableNCT07298473

Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)


Sponsor

Medtronic Cardiac Ablation Solutions

Enrollment

400 participants

Start Date

Apr 8, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia. Subjects diagnosed with symptomatic recurrent paroxysmal or persistent atrial fibrillation after a single prior ablation procedure will be enrolled in this study. Each subject will undergo a study index redo ablation procedure using the Sphere-9 Catheter and Affera Ablation System and will be followed for 12 months. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 2 years.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sphere-9 Catheter Ablation for people with atrial fibrillation (af), paroxysmal atrial fibrillation (paf), and other related conditions. The study is currently recruiting participants at 30 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESphere-9 Catheter Ablation

Redo atrial fibrillation ablation performed using the Sphere-9 Catheter in conjunction with the Affera Ablation System and Affera Mapping System. The intervention delivers radiofrequency and pulsed field energy according to the study protocol for treatment of recurrent paroxysmal or persistent AF. All participants receive this device-based ablation procedure.


Locations(30)

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, United States

Scripps Green Hospital

La Jolla, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

NCH Rooney Heart Institute

Naples, Florida, United States

AdventHealth Cardiovascular Research Institute

Orlando, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)

Kansas City, Missouri, United States

Northwell Health Lenox Hill Hospital

New Hyde Park, New York, United States

NYU Langone Health

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

OhioHealth Research and Innovation Institute (OHRI)

Columbus, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Dallas, Texas, United States

Texas Health Fort Worth

Fort Worth, Texas, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Centra Medical Group Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

Sentara Norfolk General Hospital

Newport News, Virginia, United States

Westmead Hospital

Westmead, New South Wales, Australia

Adelaide University

Adelaide, South Australia, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Universitair Ziekenhuis Brussel

Brussels, Belgium

IKEM - Institut Klinické a Experimentální Medicíny

Prague, Czechia

Motol and Homolka University Hospital

Prague, Czechia

Clinique Pasteur

Toulouse, France

Inselspital - Universitätsspital Bern

Bern, Switzerland

View Full Details on ClinicalTrials.gov

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NCT07298473


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